Pen needle exchange system

ABSTRACT

An electronic system (200) connectable to a medication delivery pen (4) and a needle assembly (2, 102), the electronic system (200) exchanging data regarding a medicament traveling from the medication delivery pen (4) to the needle assembly (2, 102), the electronic system (200) comprising a hub (202) having a spike (204) that is configured to engage the medication delivery pen (4) and pierce a reservoir septum of the medication delivery pen (4), a flow sensor (220) that is in fluid communication with the hub (202) to measure flow data of the medicament, a circuit board (250) electrically contacting the flow sensor (220) to process and transmit the flow data, the circuit board (250) including a fluid path hole (254) to route a flow of medicament, and a septum body (270, 284) that is configured to provide fluid communication between the flow sensor (220) and one of a plurality of needles (40, 124) of the needle assembly (2, 102) to administer the medicament to a patient.

This application is a continuation of U.S. patent application Ser. No.16/095,172 filed on Oct. 19, 2018, which is a U.S. national stageapplication under 35 U.S.C. § 371 of International Application No.PCT/US2017/025325, filed on Mar. 31, 2017, which claims the benefitunder 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser.62/328,670, filed on Apr. 28, 2016, all which are hereby incorporated byreference in their entirety.

FIELD

Various exemplary embodiments of the invention relate to medicationpens.

BACKGROUND

Medication pens are typically used to inject medication into a patient.A person who must periodically self-inject doses of medication willtypically carry a medication pen and several single-use pen needles. Amedication pen is designed for safety and sterility. However,inefficiencies and inconveniences arise.

SUMMARY OF THE INVENTION

It is an aspect of the present invention to provide an electronicexchange system that is attachable to a medication pen to analyzemedicament flow and communicate medicament data. Such an electronicexchange system provides advantages in separating a patient end and anon-patient end by acting as an intermediary between the medication penand an injection surface. The electronic exchange system alsoadvantageously allows for engagement and disengagement to the medicationpen. Moreover, electrical components of the electronic exchange systemare advantageously sealed from medicament flow. Specifically, themedicament flow is strategically routed around various electricalcomponents for system compactness, improved reliability and an improvedoperational interface.

Having a magazine of needles available for medication delivery reducesneedle reuse. Needle reuse is undesired for at least the followingreasons. The needle dulls after a single use and so subsequent use maycause pain to the patient. Multiple needle use can also reduce thestrength of the needle tip which may cause a potential fracture. Also,needle reuse increases sanitary concerns and health risks to thepatient.

The needle assembly of the present invention advantageously reducesreuse for at least the following reasons. Although patients may desireto financially benefit from using a needle multiple times, the needleassembly is configured to prevent each of the plurality of needles frombeing used more than once. Convenience is another reason patients reuseneedles. Patients may also be concerned about not having another needleavailable for use or not having access to supplies. However, the needleassembly conveniently provides multiple needles so that an unused needleis more readily available.

The foregoing and/or other aspects of the present invention can beachieved by providing an electronic system connectable to a medicationdelivery pen and a needle assembly, the electronic system exchangingdata regarding a medicament traveling from the medication delivery pento the needle assembly, the electronic system comprising a hub having aspike that is configured to engage the medication delivery pen andpierce a reservoir septum of the medication delivery pen, a flow sensorthat is in fluid communication with the hub to measure flow data of themedicament, a circuit board electrically contacting the flow sensor toprocess and transmit the flow data, the circuit board including a fluidpath hole to route a flow of medicament, and a septum body that isconfigured to provide fluid communication between the flow sensor andone of a plurality of needles of the needle assembly to administer themedicament to a patient.

The foregoing and/or other aspects of the present invention can also beachieved by a method of operating an electronic system connectable to amedication delivery pen and a needle assembly, the electronic systemexchanging data regarding a medicament traveling from the medicationdelivery pen to the needle assembly, the method comprising piercing areservoir septum of the medication delivery pen with a spike enclosed ina hub, connecting the medication delivery pen to the hub, providingfluid communication between the spike and a flow sensor to measure flowdata of the medicament, processing and transmitting the flow data fromthe flow sensor to a circuit board, and routing medicament flow from theflow sensor, through the circuit board and to a septum body for deliveryof the medicament to a patient when the septum body is connected to theneedle assembly.

Additional and/or other aspects and advantages of the present inventionwill be set forth in the description that follows, or will be apparentfrom the description, or may be learned by practice of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The above aspects and features of the present invention will be moreapparent from the description for the exemplary embodiments of thepresent invention taken with reference to the accompanying drawings, inwhich:

FIG. 1a illustrates a front perspective view of an exemplary electronicexchange system attached to a needle assembly;

FIG. 1b illustrates the front perspective view of the electronicexchange system attached to the needle assembly of FIG. 1a with a frameor cover removed;

FIG. 2 illustrates a front perspective view of an electronic exchangesystem connected to a medication delivery pen and attachable to a needleassembly;

FIG. 3 illustrates a cross sectional view of the electronic exchangesystem;

FIG. 4 illustrates a cross sectional view of the needle assemblyconnected to the electronic exchange system in a first position;

FIG. 5 illustrates a cross sectional view of the needle assemblyconnected to the electronic exchange system in a second position;

FIG. 6 illustrates a cross sectional view of the needle assemblyconnected to the electronic exchange system with a cover moving theneedle assembly from the second position to the first position;

FIG. 7 illustrates a cross sectional view of the needle assemblyconnected to the electronic exchange system with the cover disposed inthe first position of the needle assembly;

FIG. 8 illustrates a front perspective view of a hub;

FIG. 9 illustrates a rear perspective view of the hub;

FIG. 10 illustrates a front perspective view of the frame;

FIG. 11 illustrates a top perspective view of the frame;

FIG. 12 illustrates a bottom perspective view of the frame;

FIG. 13 illustrates a top perspective view of a flexible battery;

FIG. 14 illustrates a top perspective view of a flow sensor;

FIG. 15 illustrates a bottom perspective view of the flow sensor;

FIG. 16 illustrates a transparent perspective view of the flow sensor;

FIG. 17 illustrates a top view of a flexible circuit board in anunfolded position;

FIG. 18 illustrates a left perspective view of the flexible circuitboard in the folded position;

FIG. 19 illustrates a bottom left perspective view of the flexiblecircuit board in the folded position;

FIG. 20 illustrates a right perspective view of the flexible circuitboard in the folded position;

FIG. 21 illustrates a front perspective view of an upper septum;

FIG. 22 illustrates a bottom perspective view of the upper septum;

FIG. 23 illustrates a top perspective view of a lower septum;

FIG. 24 illustrates a bottom perspective view of the lower septum;

FIG. 25 illustrates an electronic exchange system including anactivation switch being a detector switch;

FIG. 26 illustrates an electronic exchange system including anactivation switch being a tactile switch;

FIG. 27 illustrates an electronic exchange system including anactivation switch being a hall effect sensor;

FIG. 27B illustrates a block diagram of the operation of the flexiblecircuit board in the electronic exchange system;

FIG. 28 illustrates a cross sectional view of an electronic exchangesystem connected to another embodiment of the needle assembly in a firstposition;

FIG. 29 illustrates a perspective view of an electronic exchange systemconnected to the embodiment of the needle assembly of FIG. 28 in asecond position;

FIG. 30 illustrates a front perspective view of the electronic exchangesystem connected to the needle assembly of FIG. 28 with the frameremoved; and

FIG. 31 illustrates a front perspective view of the electronic exchangesystem connected to the needle assembly of FIG. 28.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

FIGS. 1a, 1b and 2, according to one embodiment, illustrate an exemplaryelectronic exchange system 200 engaged to a needle assembly 2. Theelectronic exchange system 200 is enclosed by a frame 210 which is fixedto a hub 202 via a plurality of flanges 214. The electronic exchangesystem 200 is electrically activated for use by a tactile switch 262.Additional components of the electronic exchange system 200 include aflexible battery 236, a foam pad 240 and a flexible circuit board 250.Further details of each of these features are described below.

The electronic exchange system 200 of FIGS. 1a, 1b and 2 is connected toan exemplary needle assembly 2. The needle assembly 2 includes aselector ring 16 having a selector opening 18 that exposes a peel tab 60including a tab 64 so that one of a plurality of hollow needles 34 maybe exposed for medication delivery. Further details of the needleassembly 2 are described below.

FIG. 2, according to one embodiment, illustrates a typical medicationdelivery pen 4 used for injecting medicament, such as liquid drugs, intoa living body. The electronic exchange system 200 is mounted on themedication delivery pen 4 to analyze medicament flow. The needleassembly 2 is configured to mount on the electronic exchange system 200to enhance medication delivery by providing the plurality of needles 34with sharp proximal ends 36 for use. The needle assembly 2 can bereplaced so that the medication delivery pen 4 and the electronicexchange system 200 can continue to operate as needed. Benefits andadvantages of the electronic exchange system 200 cooperating with themedication delivery pen 4 and the needle assembly 2 are described below.

According to one embodiment, FIG. 3 illustrates a cross sectional viewof the electronic exchange system 200. The hub 202 includes a hollowspike 204 and a plurality of notches 206. As illustrated in FIGS. 8 and9, the hollow spike 204 is configured to pierce a vial, cartridge orreservoir septum (not shown) of the medication delivery pen 4. When theelectronic exchange system 200 is mounted on the medication delivery pen(non-patient end), a sharpened proximal end of the hollow spike 204pierces the reservoir septum to establish fluid communication betweenthe electronic exchange system 200 and the medication delivery pen 4.Specifically, the hollow spike 204 piercing the reservoir septumprovides fluid communication between the electronic exchange system 200and an insulin cartridge, for example, of the medication delivery pen 4.

The hub 202 also includes a plurality of notches 206 that each engagesone of the plurality of flanges 214 in the frame 210. As illustrated inFIG. 1a , the hub 202 and the plurality of notches 206 are externallyvisible to a user. The plurality of flanges 214, as illustrated in FIGS.10-12, extends from a top surface of the frame 210. Such a configurationsecures the frame 210 to the hub 202. Preferably, the hub 202 istranslucent and configured to illuminate from the light emitted fromLEDs 260. As described below, such a configuration advantageouslyindicates device status to the user since the hub 202 is externallyvisible.

The frame 210, according to one embodiment, further includes a framepocket 212 including a hole, and a protruding key 216. As illustrated inFIGS. 10-12, the frame pocket 212 is a substantially square shapedrecess along an inner diameter of the frame 210. A hole extends throughthe frame pocket 212 at its center. The frame pocket 212 is configuredto carry a substantially square shaped tactile switch 262 although avariety of shapes of the frame pocket 212 and the tactile switch 262 iscontemplated. The tactile switch 262 extends through the hole of theframe pocket 212 so that the user can compress the tactile switch 262and activate the electronic exchange system 200.

The protruding key 216 is located at a bottom inner surface of the frame210 where the components of the electronic exchange system 200 aredisposed. The protruding key 216 extends from the bottom inner surfaceto engage a corresponding groove, recess or extruded key 288 in a lowerseptum 284. This engagement provides alignment between the lower septum284 and the frame 210. Further information regarding the lower septum284 is described below.

According to one embodiment, the electronic exchange system 200 furtherincludes a flow sensor 220. The flow sensor 220, as illustrated in FIGS.14-16, include a flow sensor housing 222 that houses the electricalcomponents of the flow sensor 220. Medicament travels through a flowpath 244 in the flow sensor 220 by entering via a sensor inlet 224 andexiting via a sensor outlet 226.

As illustrated in FIG. 3, the sensor inlet 224 is centered along alongitudinal edge of the flow sensor housing 222 and is aligned with thehollow spike 204 of the hub 202 in the electronic exchange system 200.The sensor inlet 224 includes a rubber seal or O-ring seal 228 thatprovides a hermetic or leak free interface between the flow sensor 220and the hub 202. Such a configuration advantageously prevents medicamentfrom contacting electrical components in the electronic exchange system200. The sensor outlet 226 engages an upper septum 270 to establishfluid communication as described below.

The flow sensor 220 is advantageously configured so that there is nodirect fluid contact between the medicament and a sensor chip or otherelectrical components. Instead, the flow path 244 routes the medicamentthrough the flow sensor housing 222 to measure and extract the necessarymedicament flow data. Preferably, the flow sensor 220 is a SensirionLPG10 flow sensor.

The flow sensor 220 further includes electrical contacts 230. Theelectrical contacts 230 are disposed on an external surface of the flowsensor housing 222 to communicate flow data. In the electronic exchangesystem 200, the flexible circuit board 250 is electrically connected tothe flow sensor housing 222 of the flow sensor 220 to receive andanalyze the medicament flow data.

The electronic exchange system 200, according to one embodiment, alsoincludes the printed circuit board 250. Preferably, the printed circuitboard 250 is a flexible circuit board. FIG. 17 illustrates the flexiblecircuit board 250 in a flat condition prior to folding (unfoldedposition), whereas FIGS. 18-20 illustrate the flexible circuit board 250in its operational condition after folding (folded position). Asillustrated in FIG. 3, the flexible circuit board 250 in the foldedposition in the electronic exchange system 200 advantageously provides acompact arrangement of electronics. The following components of theflexible circuit board 250 are described in view of the folded position.

The flexible circuit board 250 includes battery connector pads 252 thatelectrically connect to battery contacts 238 of a battery 236 asillustrated in FIGS. 13 and 18-20. The battery 236 is preferably aflexible battery with a step-up converter to increase voltage.Alternately, the battery 236 includes two flexible batteries stackedtogether in series, each with a voltage capacity of approximately threevolts, for example.

The battery 236 advantageously aids to provide a compact arrangement ofelectronics in the electronic exchange system 200. Preferably, thebattery 236 includes three battery contacts 238. The battery contacts238 of the battery 236 are spaced apart from each other in acircumferential direction and disposed at a distal end of the battery236. The battery 236 surrounds the flexible circuit board 250 byapproximately 315° when assembled in the electronic exchange system 200.

The battery connector pads 252 are also spaced apart from each other ina circumferential direction and disposed at a distal end of the flexiblecircuit board 250. The battery contacts 238 of the battery 236 align andcontact the battery connector pads 252 of the flexible circuit board250. The battery 236 provides electrical energy for the electroniccomponents in the electronic exchange system 200 to operate.

The flexible circuit board 250 further includes a fluid path hole 254.Alternatively, the fluid path hole 254 is a cutaway portion at acircumferential edge of the flexible circuit board 250. As illustratedin FIGS. 3 and 18-20, the fluid path hold 254 is disposed on ahorizontal surface of the flexible circuit board 250. Specifically, asillustrated in FIG. 3, the horizontal surface of the flexible circuitboard 250 is disposed between the flow sensor 220 and the upper septum270. The fluid path hole 254 advantageously allows the medicament flowto travel through the flexible circuit board 250. Specifically, thefluid path hole 254 allows the sensor outlet 226 to engage the upperseptum 270. The fluid path hole 254 advantageously allows for a compactarrangement of electronics in the electronic exchange system 200 withoutinconveniently rerouting the flow path 244 around various components.

As described above, the flow sensor 220 is connected to the flexiblecircuit board 250 via a sensor connector pad 256. As illustrated inFIGS. 18 and 20, the sensor connector pad 256 is disposed horizontallyand adjacent to the horizontal surface of the flexible circuit board 250in the folded position. The sensor connector pad 256 is also disposedadjacent to the fluid path hole 254 and below the flow sensor 220.Accordingly, the sensor connector pad 256 aligns with the electricalcontacts 230 of the flow sensor 220 when the exchange system 200 isassembled. In this manner, the flexible circuit board 250 advantageouslyreceives the flow data from the flow sensor 220 for further analysis andprocessing. Moreover, such transfer of flow data from the flow sensor220 to the flexible circuit board 250 advantageously occurs through acompact arrangement of electronics in the electronic exchange system200.

As illustrated in FIG. 20, various circuit board components 258 areconnected to the flexible circuit board 250. According to oneembodiment, some of these components include a plurality of lightemitting diodes (LEDs) 260, a tactile switch 262, a Bluetooth chip 264,a memory chip 266 and a microprocessor 268.

In an alternate configuration, a microprocessor and a memory chipincluded in a standard Bluetooth chip may be sufficient and not requirethese components separately on the flexible circuit board 250. In thisinstance, the Bluetooth chip will require various simple circuitelements such as resistors, capacitators and diodes to functionproperly.

The plurality of LEDs 260, as illustrated in FIGS. 18 and 19, preferablyincludes three LEDs 260. The LEDs 260 are disposed and spaced apart fromeach other on a circumferential surface of the flexible circuit board250. The circumferential surface is disposed at a proximal end of theflexible circuit board 250. The LEDs 260 indicate device status.

For example, if the LEDs 260 are together illuminating solid light, theelectronic exchange system 200 is powered on and ready for operation. Ifthe LEDs 260 are together blinking, the medicament is being deliveredand will continue to blink for ten seconds after the dose is deliveredto the patient. If the LEDs 260 are together not illuminated, theelectronic exchange system 200 is powered off. Alternately, the LEDs 260can illuminate in different colors or individually to indicate devicestatus. For example, the LEDs 260 can illuminate different colors toindicate various error conditions (clogging or low battery, forexample), as well as pairing status with a Bluetooth enabled externaldevice.

As described above, the LEDs 268 also indicate when the electronicexchange system 200 is paired to an external system such as a smartphone or a computer. Moreover, the LEDs 260 are illuminated duringdosing to indicate flow status such as in “progress,” “complete,”“clogging,” when the electrical communication is paired for real-timetransfer of delivery data to the external system, and when the user canremove the delivery device needle (e.g., flow rate indicates injectionis complete, or the microprocessor 268 determines the flow over adesignated period of time matches an inputted dose amount), among otherstates.

Preferably, the hub 202 is translucent and configured to receive thelight emitted from the LEDs 260. The hub 202 is configured to diffusethe light emitted by the LEDs 260 around an entire outer perimeter ofthe needle assembly 2 and the electronic exchange system 200. In thismanner, the device status of the electronic exchange system 200 is moreobvious from various viewing angles. Also, the device status of theelectronic exchange system 200 is determined by the user based onillumination of the hub 202.

As illustrated in FIGS. 18 and 20, the tactile switch 262 is connectedon a side surface of the flexible circuit board 250. The side surface isa vertical surface connecting the horizontal surface, including thefluid path hole 254, and the circumferential surface, including theplurality of LEDs 260, of the flexible circuit board 250. FIG. 3illustrates that the tactile switch 262 is disposed within the hole inthe frame pocket 212 of the frame 210. The tactile switch 262 extendsthrough the hole of the frame pocket 212 so that the user can compressthe tactile switch 262 to operate (i.e. activate and deactivate) theelectronic exchange system 200.

As illustrated in FIGS. 19 and 20, the Bluetooth chip 264 is alsodisposed on the horizontal surface of the flexible circuit board 250. Inthe electronic exchange system 200, the Bluetooth chip 264 is disposedabove and adjacent to the upper septum 270. The Bluetooth chip 264provides data communication between the electronic exchange system 200and the external system. Alternatively, Wi-Fi technology can be used inplace of the Bluetooth chip 264 for similar purposes.

FIG. 20 illustrates the memory chip 266 disposed on the horizontalsurface of the flexible circuit board 250. The memory chip 266 storesinformation when the flow data or any processed information is nottransferred to the external system.

According to an alternate embodiment, data provided during orimmediately after injection from the electronic exchange system 200 isautomatically transferred and stored at a memory device in the externalsystem with a time stamp using a clock in the external system. In thismanner, the electronic exchange system 200 does not process the flowdata. Instead, while dosing is in progress, the external system can beconfigured by an app, for example, to receive and process flow data todetermine flow rate over time, total dose and other flow and dosingcharacteristics.

FIG. 20 also illustrates the microprocessor 268 disposed on the flexiblecircuit board 250. The microprocessor 268 provides the followingfunctional advantages and benefits. The microprocessor 268 receives adesired dose from the user via the Bluetooth chip 264 and analyzes theflow data received from the flow sensor 220 to determine a dose deliverycompletion status. The microprocessor 268 measures time through a globalpositioning system (GPS) or alternatively includes a real time clock(e.g., Abracon AB-RTCMC real-time clock module or equivalent thereof).The microprocessor 268 uses this time data to determine rate of deliveryand time of delivery completion. When the dosing is being administered,the microprocessor 268 receives flow data from the flow sensor 220 anddetermines how much time is needed to deliver the desired dose, totaldose delivered, dose time, dose rate, or dose status such as “inprogress” or “complete.” Additionally, flow data during deliveryindicates issues such as clogging and generates user alerts duringdosing. The microprocessor 268 also calculates a dose history for theuser to access.

The microprocessor 268 transfers the data regarding drug delivery status(e.g., complete or in progress, as described above) or other deliveryinformation (e.g., rate, timing, as described above) in real-time (e.g.,during injection) or at any time such as after injection. For example,the electronic exchange system 200 captures time of dose and sendstiming information with flow and total amount delivered data to theexternal system. This transfer occurs via the Wi-Fi technology or theBluetooth chip 264 as described above.

According to one embodiment, the foam pad 240 has a cylindrical shapesimilar to the flexible battery 236. However, the foam pad 240 istubular shaped. The foam pad 240 is adjacent to the hub 202 and the flowsensor 220 at an inner diameter surface of the foam pad 240. The foampad 240 is also adjacent to the flexible battery 236 and the flexiblecircuit board 250 at an outer diameter surface of the foam pad 240.Thus, the foam pad 240 is advantageously disposed between variouscomponents of the electronic exchange system 200.

The foam pad 240 advantageously provides a small force when compressed.The arrangement of components in the electronic exchange system 200 asillustrated in FIG. 3, compresses the foam pad 240 resulting in acompression force. Accordingly, the tactile switch 262 of the flexiblecircuit board 250 receives the compression force from the foam pad 240.This compression force ensures that the tactile switch 262 protrudes outof the hole in the pocket 212 of the frame 210 throughout operation ofthe electronic exchange system 200.

According to one embodiment, the electronic exchange system 200 furtherincludes the upper septum 270 and the lower septum 284 (generallytogether referred to as septum body 270/284). FIGS. 21 and 22 illustratethe upper septum 270 including an input chamber 272 being a throughhole. The input chamber 272 is offset from and not in-line with thecenter of the upper septum 270. A proximal end of the input chamber 272connects to the sensor outlet 226 of the flow sensor 220. A distal endof the input chamber 272 is in fluid communication with a deliverychamber 274. The input chamber 272 allows liquid medicament to flow fromthe medication delivery pen 4 and to the delivery chamber 274.

The delivery chamber 274 is formed when the upper and lower septums 270,284 are joined together. Specifically, the upper septum 270 furtherincludes a first diameter 278, a second diameter 280 and a thirddiameter 282. The first diameter 278 is the largest of the threediameters that covers the lower septum 284. The delivery chamber 274 isdisposed between outer surfaces of the second and third diameters 280,282 of the upper septum 270. Further details of the delivery chamber 274are described below.

The upper septum 270 further includes an alignment keyhole 276. Thealignment keyhole 276 is disposed at a distal end of the upper septum270. The alignment keyhole 276 is a partially extruded hole and key slotat a bottom face of the third diameter 282. The alignment keyhole 276mates with a corresponding alignment protrusion 286 in the lower septum284 for proper orientation of the upper and lower septums 270, 284.

The lower septum 284 or priming septum is illustrated in FIGS. 23 and24. The lower septum 284 includes the alignment protrusion 286 thatmates with the alignment keyhole 276 of the upper septum 270 asdescribed above. The alignment protrusion 286 extends from a bottominner surface 294 of the lower septum 284.

The lower septum 284 also includes the groove, recess or extruded key288 disposed at an exterior bottom surface of the lower septum 284. Asdescribed above, the groove 288 mates with the protruding key 216located at the bottom inner surface of the frame 210. This featureorients the lower septum 284 and the delivery chamber 274 to the frame210 for proper operation.

The lower septum 284 further includes an inner diameter 290 and an outerdiameter 292. The inner diameter 290 mates with the second diameter 280of the upper septum 270 and provides direct sealing contact. Thedelivery chamber 274 is thus formed within the inner diameter 290 andabove the bottom inner surface 294 of the lower septum 284, as well asoutside the third diameter 282 and below bottom surface of the seconddiameter 280 of the upper septum 270. The input chamber 272 is alignedto be in fluid communication with the delivery chamber 274. Thus, thedelivery chamber 274 stores the medicament received from the inputchamber 272 for medication delivery via an exemplary needle assembly.

The upper septum 270 is secured to the lower septum 284 via an annularsnap fit or an interference fit, for example. The upper septum 270 andthe lower septum 284 are preferably composed of different materialshaving different durometers. Such characteristics enhance sealingbetween the second diameter 280 of the upper septum 270 and the innerdiameter 290 of the lower septum 284.

The electronic exchange system 200, according to one embodiment, canprovide alternate means for activation instead of using the tactileswitch 262 in the flexible circuit board 250. FIGS. 25-27 illustratevarious activation switches 242. Each of the activation switches 242 areinitiated when the user moves a housing 110 of the needle assembly 102,as described further below. When the activation switch 242 is turned on,the LED 260 is illuminated in a similar manner as described above toshow readiness of the electronic exchange system 200.

FIG. 25 illustrates the activation switch 242 being a detector switch243 a. The detector switch 243 a will detect and determine when thehousing 110 covers a predetermined portion of the electronic exchangesystem 200 to activate the electronic exchange system 200. FIG. 26illustrates the activation switch 242 being a flanged switch 243 b. Whenthe housing 110 moves and covers a predetermined portion of theelectronic exchange system 200, the flanged switch 243 b deflects andthus activates the electronic exchange system 200. FIG. 27 illustratesthe activation switch 242 being a Hall Effect sensor 243 c. The HallEffect sensor 243 c includes a magnet and a Hall Effect switch. Themagnet is disposed in the housing 110 and the Hall Effect switch isdisposed on an exterior surface of the electronic exchange system 200.When the housing 110 moves and aligns the magnet to the Hall Effectswitch, the Hall Effect sensor 243 c activates the electronic exchangesystem 200.

FIG. 27B illustrates a block diagram showing the operation of theflexible circuit board 250 in the magazine electronic exchange system200. Specifically, the memory chip 266, the activation switch 242, thepower source and regulation (i.e. the flexible battery) 236 and the flowsensor 220 cooperate with the microprocessor 268 for appropriateoperation as described above. The microprocessor 268 also communicateswith the wireless module (i.e. Bluetooth chip) 264 and the tactileswitch 262 for efficient power usage and transfer of data.

FIGS. 1a, 1b , 2, 4 and 5, according to one embodiment, illustrate theneedle assembly 2 that connects to the electronic exchange system 200.Specifically, a sharpened proximal end 36 of the plurality of hollowneedles 34 is disposed in the upper septum 270 in a first position ofthe needle assembly 2 as illustrated in FIG. 4. The plurality of needles34 extends through the delivery chamber 274, thus contacting themedicament. However, the plurality of needles 34 is not in fluidcommunication with the delivery chamber 274.

In a second position of the needle assembly 2, as illustrated in FIG. 5,one of the plurality of needles 34 is exposed for medicament delivery.In this instance, a proximal end 42 of a selected needle 40 is disposedin the delivery chamber 274 to receive medicament. A distal end 44 ofthe selected needle 40 is exposed for medication delivery.

The operation of the needle assembly 2 connected to the electronicexchange system 200 is now explained in an exemplary manner as follows.According to one embodiment, the user aligns and connects the needleassembly 2 to the electronic exchange system 200. When the user desiresto use the needle assembly 2 for medication delivery, the selector ring16 is rotated to align with a peel tab 60 as illustrated in FIGS. 1a, 1band 2. As illustrated in FIGS. 4 and 5, the user bends the tab 64 of thepeel tab 60 of the selected needle 40 from a retracted, compact positionto an extended position.

Next, the user pulls the tab 64 of the peel tab 60 of the selectedneedle 40 and moves the needle assembly 2 from the first position ofFIG. 4 to the second position of FIG. 5. When the selected needle 40 isfully drawn out, the needle assembly 2 is in the second position.Subsequently, the sterility barrier 60 is removed from the selectedneedle 40 and the needle assembly 2 is ready for medicament delivery.When the needle assembly 2 moves from the first position to the secondposition, the needle post 50 of the selected needle 40 moves from a topposition to a bottom position.

In the second position of the needle assembly 2, a proximal end 42 ofthe selected needle 40 also enters into fluid communication with thedelivery chamber 274 of the electronic exchange system 200. A distal end44 of the selected needle 40 exits the selector ring 16 and is exposedfor medication delivery. Accordingly, medicament is received by theproximal end 42 of the selected needle 40 and exits the distal end 44 ofthe selected needle 40 to be delivered to a patient.

When the first needle of the plurality of needles 34 is used, thedelivery chamber 274 is filled with medicament, resulting in the needleassembly septum 270, 284 being primed. Specifically, medicament musttraverse and fill the complete fluid path of the delivery chamber 274 toreach the first needle of the plurality of needles 34. Accordingly, theincidence of air in the delivery chamber 274 is advantageously reduced.Removing air from the fluid path also advantageously improves doseaccuracy.

FIGS. 6 and 7, according to one embodiment, illustrate the use of acover 80 to return the needle assembly 2 from the second position to thefirst position. The cover 80 includes a cylinder 82, a base 84 and aprotrusion 86. The cylinder 82 is configured to surround the needleassembly 2. The base 84 is configured to cover a bottom portion of theselector ring 16 of the needle assembly 2. The protrusion 86 extendsfrom the base 84 and is disposed centrally within the cylinder 82. Whenthe cover 80 is placed on the needle assembly 2, the protrusion 86enters a selector hole 17 in the selector ring 16. The protrusion 86 ofthe cover 80 applies pressure by pushing the needle post flange 52 ofthe needle post 50 of the selected needle 40 from the bottom position tothe top position.

FIG. 6 illustrate the needle assembly 2 moving from the second positionto the first position and FIG. 7 illustrates the second position of theneedle assembly 2. These figures also illustrate that the needle postflanges 52 of each of the plurality of needles 34 are arranged toward acentral axis of the selector ring 16. Such a configurationadvantageously allows the protrusion 86 of the cover 80 to engage eachof the plurality of needle posts flanges 52 in the selector hole 17 tomove the needle post 50 from the bottom position to the top position.

After the needle assembly 2 is returned to the first position, accordingto one embodiment, an adjacent needle is preferably selected for use.The selector ring 16 is then rotated to expose an adjacent peel tab 60of the adjacent needle. However, the user has the flexibility to exposeand choose any of the remaining plurality of peel tabs 60.

Once a needle and respective peel tab 60 is selected, the selected peeltab 60 is removed for operation in the manner described above. Theselected needle 40 is then used for medication delivery and afterwards,the cover 80 is used to return the selected needle 40 to the firstposition of the needle assembly 2. These steps are repeated until all ofthe plurality of needles 34 is used. The combination of the selectorring 16 and the plurality of peel tabs 60 simplify the needle assembly2, allow for easy to use operation and improve safety.

Each of the plurality of needles 34 is advantageously isolated from theseptum of the medication delivery pen 4 throughout the operation of theelectronic exchange system 200 and the needle assembly 2. Also, theneedle assemblies 2, 102 can include a USB port to transfer data. Suchan arrangement advantageously provides simplicity in design, improvessterility, allows data transfer and provides a separation between apatient end and a non-patient end.

FIGS. 28-31 illustrate the electronic exchange system 200 cooperatingwith another exemplary needle assembly 102. The following describes theoperation of the needle assembly 102. According to one embodiment, theneedle assembly 102 moves from a first position, as illustrated in FIG.28, and toward a second position, as illustrated in FIG. 29, where asharpened distal end 128 of a selected needle 124 of a plurality ofhollow needles 118 is exposed for medicament delivery. As the needleassembly 102 leaves the first position, the distal end 128 of theselected needle 124 begins to pierce a sealing septum 150 and theremaining plurality of needles 118 are all sealed and sterilized in thesealing septum 150 of the needle assembly 102.

When the housing 110 moves downward, a follower ring 130 and a snap ring136 move downward as well. As the follower ring 130 moves downward, afollower 132 at a bottom portion of the follower ring 130 engages one ofa plurality of external fins 145 of a bottom guide 144. Specifically,the follower 132 contacts one of the plurality of external fins 145 andthe follower 132 slides along its tooth shaped edge to rotate thefollower ring 130 while maintaining contact with the external fin 145.

A snap ring 136 also rotates because the snap ring 136 is rotationallyconnected to the follower ring 130. Since the snap ring 136 isrotationally coupled to the follower ring 130, the snap ring 136 appliespressure to an extending portion 142 of a needle post 140 of theselected needle 124. As a result, FIG. 29 illustrates the distal end 128of the selected needle 124 piercing the sealing septum 150 of the needleassembly 102 and exposing the selected needle 124 for medicationdelivery.

When the needle assembly 102 is in the second position, as illustratedin FIG. 29, the selected needle 124 amongst the plurality of needles 118is exposed for medicament delivery. Specifically, the follower 132 hascompleted rotation and is disposed between external fins 145 of thebottom guide 144. The distal end 128 of the selected needle 124 is readyfor medication delivery. In this second position, a proximal end of theselected needle 124 enters into fluid communication with the deliverychamber 274 and the sharpened distal end 128 of the selected needle 124pierces the sealing septum 150 and is exposed. Each of the plurality ofneedles 118 is aligned and configured to be in fluid communication withthe delivery chamber 274 when selected by the snap ring 136. Theproximal end 120 of the remaining needles 118 continues to be disposedin the upper septum 270. The distal end 122 of the remaining needles 118also continues to stay sealed and sterilized in the sealing septum 150of the needle assembly 102.

When the needle assembly 102 returns from the second position back tothe first position as illustrated in FIG. 28, the user pulls the housing110 back toward the medication delivery pen 4. At the same time, a cappushes the snap ring 136 and the follower ring 130 upwards which movesthe extending portion 142 of the needle post 140 of the selected needle124 upward. The distal end 128 of the selected needle 124 returns intothe sealing septum 150 of the needle assembly 102. The sealing septum150 encloses the selected needle 124 and protects the user.

Meanwhile, the follower 132 at the top portion of the follower ring 130contacts one of a plurality of ridges 117 of a septum housing 114 andcauses the follower ring 130 to rotate. The plurality of ridges 117 canbe disposed externally or internally to the septum housing 114. Thefollower 132 at the top portion of the follower ring 130 contacts one ofthe plurality of external ridges 117 of the septum housing 114 and thefollower 132 slides along its tooth shaped edge to rotate the followerring 130 while maintaining contact with the external ridge 117.

As the needle assembly 102 returns to the first position, as illustratedin FIG. 28, the follower ring 130 rotates and prepares the snap ring 136to align with an adjacent needle of the plurality of needles 118 for asubsequent injection. Specifically, the snap ring 136 elasticallydeflects in a radial direction and snaps over the extending portion 142of the needle post 140 of the adjacent needle of the plurality ofneedles 118. In this manner, the next needle in the needle assembly 102is ready for subsequent use.

The process of moving from the first position to the second position andback to the first position while rotating the snap ring 136 repeats inthe manner describe above so that each needle amongst the plurality ofneedles 118 of the needle assembly 102 is individually exposed in aconsecutive manner from a first needle, to each adjacent needle and to alast needle.

The foregoing detailed description of the certain exemplary embodimentshas been provided for the purpose of explaining the principles of theinvention and its practical application, thereby enabling others skilledin the art to understand the invention for various embodiments and withvarious modifications as are suited to the particular use contemplated.This description is not necessarily intended to be exhaustive or tolimit the invention to the precise embodiments disclosed. Any of theembodiments and/or elements disclosed herein may be combined with oneanother to form various additional embodiments not specificallydisclosed, as long as they do not contradict each other. Accordingly,additional embodiments are possible and are intended to be encompassedwithin this specification and the scope of the invention. Thespecification describes specific examples to accomplish a more generalgoal that may be accomplished in another way.

As used in this application, the terms “front,” “rear,” “upper,”“lower,” “upwardly,” “downwardly,” and other orientational descriptorsare intended to facilitate the description of the exemplary embodimentsof the present invention, and are not intended to limit the structure ofthe exemplary embodiments of the present invention to any particularposition or orientation. Terms of degree, such as “substantially” or“approximately” are understood by those of ordinary skill to refer toreasonable ranges outside of the given value, for example, generaltolerances associated with manufacturing, assembly, and use of thedescribed embodiments.

1. An electronic system connectable to a medication delivery pen, theelectronic system exchanging data regarding a medicament exiting themedication delivery pen into the electronic system, the electronicsystem comprising: a flow sensor that detects the medicament receivedfrom the medication delivery pen to measure flow data of the medicament;a circuit board electrically contacting the flow sensor to process andtransmit the flow data; and a septum body that is configured to controlmedicament exiting the electronic system.
 2. The electronic system ofclaim 1, further comprising: a hub having a spike that is configured toengage the medication delivery pen and pierce a reservoir septum of themedication delivery pen; and the flow sensor includes an O-ring thatseals an interface between the hub and the flow sensor.
 3. Theelectronic system of claim 1, further comprising a foam pad surroundingthe flow sensor and applying a force to the circuit board.
 4. Theelectronic system of claim 3, further comprising a flexible batterypartially surrounding the foam pad.
 5. The electronic system of claim 3,wherein the circuit board surrounds the foam pad.
 6. The electronicsystem of claim 4, wherein the flexible battery partially surrounds thecircuit board.
 7. The electronic system of claim 4, wherein the flexiblebattery electrically contacts a distal end of the circuit board.
 8. Theelectronic system of claim 1, wherein the circuit board comprises aflexible circuit board.
 9. The electronic system of claim 1, wherein theseptum body includes an input chamber and a delivery chamber; and theinput chamber transfers the medicament from the flow sensor to thedelivery chamber.
 10. The electronic system of claim 1, wherein thecircuit board is disposed between the flow sensor and the septum body.11. The electronic system of claim 1, further comprising a frame thatencloses the electronic system, the frame including a hole; and thecircuit board includes a switch, wherein the switch is disposed in thehole of the frame and extends through the hole.
 12. The electronicsystem of claim 11, wherein a foam pad applies a force to the switch sothat the switch projects through the hole of the frame throughoutoperation.
 13. The electronic system of claim 1, wherein the septum bodyincludes an upper septum and a lower septum; and an inner surface of thelower septum and an outer surface of the upper septum form a deliverychamber.
 14. The electronic system of claim 1, further comprising anactivation switch to activate the flow sensor for operation.
 13. Theelectronic system of claim 1, wherein the medicament flows within theflow sensor in a direction perpendicular to a centerline of themedication delivery pen.
 14. The electronic system of claim 1, whereinthe flow sensor includes a flow sensor inlet and a flow sensor outlet.15. The electronic system of claim 2, wherein a flow sensor inlet of theflow sensor engages the hub.
 16. The electronic system of claim 1,wherein a flow sensor outlet engages the septum body.
 17. The electronicsystem of claim 16, wherein an interface between the flow sensor outletand the septum body is sealed.
 18. The electronic system of claim 1,wherein the medicament travels from the flow sensor, through the circuitboard, and to the septum body.
 19. The electronic system of claim 1,wherein the medicament travels from the flow sensor, around the circuitboard, and to the septum body.
 20. A method of operating an electronicsystem connectable to a medication delivery pen and a needle assembly,the electronic system exchanging data regarding a medicament travelingfrom the medication delivery pen to the needle assembly, the methodcomprising: fluidly connecting the medication delivery pen to a flowsensor; providing the medicament to flow from the medication deliverypen to the flow sensor to measure flow data of the medicament;processing and transmitting the flow data from the flow sensor to acircuit board; and routing the medicament flow from the flow sensor to aseptum body of the electronic system.